Quality Engineer
Company: Dentsply Sirona
Location: Bausman
Posted on: January 3, 2026
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Job Description:
The QA Engineer plays a critical role in ensuring the
effectiveness, compliance, and continuous improvement of the
Quality Management System (QMS) within the Lancaster Distribution
Center and the broader North American distribution network. This
position is responsible for developing, implementing, and
maintaining robust quality system processes, including supplier
controls, internal audits, and supporting external audits conducted
by regulatory agencies. The QA Engineer serves as a key driver of
quality excellence across distribution operations, ensuring
alignment with regulatory requirements, corporate standards, and
customer expectations. Key Responsibilities: • Maintain systems,
processes, and documentation to support compliance with FDA, ISO
13485, and other applicable international quality standards. • Lead
quality-related activities for standard and specialized
distribution processes, including country-specific labeling,
supplemental labeling, and other market-specific requirements. •
Ensure proactive and effective fulfillment of distributor,
repackager, relabeler, and initial importer regulatory requirements
across the Lancaster Distribution Center and the North American
distribution network. • Manage the quality intake and evaluation of
new activity requests to ensure alignment with regulatory and
internal quality standards. • Lead and coordinate Nonconformances
(NCs), Corrective and Preventive Actions (CAPAs), and Change
Control processes to ensure timely resolution of issues and
controlled implementation of changes. • Establish, monitor,
analyze, and report on key performance indicators (KPIs) and
quality metrics to identify trends, drive continuous improvement,
and support strategic decision-making. • Collaborate with internal
stakeholders to ensure readiness for inspections and audits related
to distribution, repackaging, relabeling, and importing activities.
• Monitor regulatory and industry changes, assess their impact on
distribution processes, and ensure timely updates to procedures and
internal controls. • Support the development and implementation of
quality strategies that enhance compliance and reduce risk across
the supply chain. • Act as a liaison between the distribution
center and regulatory, commercial, and supply chain partners to
ensure alignment and transparency regarding quality requirements
and expectations. • Partner with Operations and Supply Chain teams
to troubleshoot and resolve system-specific quality issues.
Experience & Qualifications: • 3 to 5 years of experience in
Quality Assurance, ideally within a regulated environment. • Prior
experience in the medical device and/or pharmaceutical industry
required.
Keywords: Dentsply Sirona, Wilmington , Quality Engineer, Science, Research & Development , Bausman, Delaware
